Original-Research: Cardiol Therapeutics - von GBC AG

Einstufung von GBC AG zu Cardiol Therapeutics

Unternehmen: Cardiol Therapeutics
ISIN: CA14161Y2006

Anlass der Studie: Research Comment
Letzte Ratingänderung: -
Analyst: Julien Desrosiers; Felix Haugg

GBC Research Watchlist: Cardiol Therapeutics Inc.

'The right moment to participate in this exciting growth story'

Cortalex - The purest form of CBD, no THC. It matters.

For many patient segments, CBD medication can be linked to the possibility of becoming intoxicated by THC. For children, young adults under 25, workers that cannot be intoxicated at work, or the elderly, having access to a CBD formulation that does not contain intoxicating amounts of THC is of the upmost importance. These consumers represent an important part of the medical CBD market. Specifically, the elderly population (over 65 years old) is the fastest growing segment of the almost $600 million medicinal cannabinoid market in Canada.

One of the main issues in the medicinal cannabinoid market is purity. When clients are looking for a high concentration of CBD, they often sacrifice product purity as the level of THC and other impurities rises significantly. This issue can prove to be a real challenge for those patients mentioned above.

Cortalex(TM), the company's commercial oral CBD formulation product, is pharmaceutically produced and formulated to be consistent from batch to batch with proven purity and stability. Containing less than 10 parts per million THC, it is considered THC free. Their exclusive manufacturing partner, Dalton Pharma Services, is cGMP compliant and meets the highest standards set by the pharmaceutical industry. CBD has been shown to be effective in treating seizures associated with the pediatric epi- lepsies Dravet and Lennox-Gastaut Syndromes, and tuberous sclerosis complex1. There are also claimed benefits of CBD in the treatment of medical conditions including: anxiety, sleep disorders, depression, and chronic pain2.

To the best of our knowledge, of the high concentration oral CBD formulations currently available in the Canadian medical market, Cortalex is by far the purest, containing virtually undetectable levels of THC (<10ppm).

CardiolRx(TM) - targeting inflammatory heart disease

The company is following a strategy similar to GW Pharmaceuticals (GW), the developer of the FDA approved high concentration CBD formulation for rare forms of pediatric epilepsy. This strategy led to the recently announced acquisition of GW pharma by Jazz Pharmaceuticals for over USD $7 billion. This acquisition serves as a powerful validation of Cardiol Therapeutics' business model, as it demon strates the magnitude of shareholder value that can be created by developing pure cannabidiol med icines for important disease targets. In the case of Cardiol, these disease targets include acute myo- carditis and heart failure, poorly served inflammatory heart diseases that represent much larger mar kets than the pediatric epilepsies.

Acute Myocarditis - Phase I completed and Phase II in the Approval Process

Cardiol Therapeutics recently successfully completed a Phase I study of CardiolRx. The randomized controlled study was completed without any serious adverse events reported. The complete report of the 52 healthy adult subjects should be published during early Q2 2021. The Phase I study is intended to test the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending doses of Cardi- olRx(TM).

The company has announced its intention to file an IND application with the U.S. FDA for an interna- tional Phase II clinical trial. Acute myocarditis is recognized as an orphan disease making Cardiol's CBD formulation eligible for orphan drug designation - the same designation GW pharma was granted by the FDA which enabled the fast-track development of their CBD formulation in rare pediatric epi- lepsies. In the U.S. and other major international markets, any disease that affects fewer than 200,000 people nationwide qualifies for orphan drug status. An orphan drug allows for accelerated marketing approvals and the company developing the drug can benefit from numerous incentives, such as a prolonged period of marketing exclusivity.

Cardiol's planned Phase II program in Acute Myocarditis is an international study designed to recruit 100 patients at major cardiovascular research centers in Canada, the U.S., and Europe. The study will assess the cardioprotective effects of its high concentration CBD formulation, CardiolRx, versus placebo, on key measures of myocardial (heart muscle) recovery including: i) Left ventricular ejec- tion fraction, ii) Extracellular volume and iii) Global longitudinal strain.

High risk COVID-19 patients with history of cardiovascular disease Cardiol could help

Following an IND application approved by the U.S. FDA, the company is preparing a Phase II/III clinical trial to assess the safety and effectiveness of their CardiolRx formulation on 422 COVID-19 hospitalized patients at clinical centers throughout the U.S. Each patient will have a history of, or risk factors for, cardiovascular disease. Due to the severity of the COVID-19 situation worldwide, this trial could result in an accelerated approval. The company has engaged the services of Worldwide Clinical Trials to act as Contract Research Organization ('CRO'). The company's independent Steering Com- mittee and Data Safety Monitoring Committee comprise world renown specialists in heart failure, acute myocarditis, and other inflammatory heart diseases.

Specifically, the trial will assess the cardioprotective effects of CardiolRx on reducing a composite of the following significant adverse outcomes: i) all-cause mortality, ii) requirement for ICU admission and/or ventilatory support, and iii) cardiovascular complications, including the development of heart failure, acute myocardial infarction, myocarditis, stroke, or new sustained or symptomatic arrhythmia. The study will compare the cardioprotective effects of CardiolRx versus placebo after 28 days of treatment.

CardiolRx, well positioned during and beyond the current pandemic

As all eyes remain on the current COVID-19 pandemic, it is important to note that as a result of a global increase in diabetes, high blood pressure and obesity, heart failure was an epidemic before COVID-19 and will remain an epidemic during and after COVID-19. Regardless of how the COVID-19 pandemic plays out, there remains a desperate need for new forms of treatment for heart failure and to the extent that COVID-19 becomes endemic, there will be a need for a cardioprotective treatments for highrisk patients for many years to come.

Diastolic heart failure - Incredible Future Potential

Cardiol's research has demonstrated that a new formulation of CardiolRx that will be delivered like insulin significantly reduced inflammation in a model of heart failure. This treatment is still in the pre- clinical development stage but holds tremendous promise for the future. Heart failure affects over 26 million people in the developed world and remains a leading cause of death and hospitalization, with associated annual healthcare costs in the U.S. alone exceeding $30 billion.

Well-funded - Cash on account for the studies

The company had cash on hand as of September 30, 2020 of $16.5M CDN and recently raised pro- ceeds of over CAD $10M from warrant and option exercises.

Leadership - An experienced team that is up to the task at hand

Cardiol Therapeutics is led by David Elsley. He has already been through the Phase III approval process for an inflammatory heart treatment, as CEO of a public company prior to founding Cardiol Therapeutics. He has surrounded himself with a team of experts with decades of experience in developing new therapeutics for cardiovascular disease. Cardiol's COVID-19 and acute myocarditis Steering Committee comprise thought leaders in heart disease from around the globe, including representation from prestigious institutions such as the Heart Failure/Transplantation Program at the University of Pittsburgh Medical Center, the Mayo Clinic, McGill University, Ottawa Heart Institute, the Charité University Hospital in Berlin, and many more.

Entering NASDAQ - Application for up-listing recently filed

The company has filed its application to be uplisted on the NASDAQ. With a market cap of approx.

$200M CDN, the company currently trades on the TSX: CRDL, OTCQX: CRTPF and FSE: CT9. GBC Initial Coverage Research Report coming soon.

Die vollständige Analyse können Sie hier downloaden: http://www.more-ir.de/d/22241.pdf

Kontakt für Rückfragen
Jörg Grunwald
Vorstand
GBC AG
Halderstraße 27
86150 Augsburg
0821 / 241133 0
research@gbc-ag.de
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Date (time) of completion of English version: 11/03/2021 (12:45 pm) Date (time) of first distribution of English version: 11/03/2021 (03:15 pm)

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